Review of Chemical Analytical Procedures

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and Research

Memorandum

Date:	August 10, 2007
To:	Rakesh Pandey Ph.D. OVRR/DVRPA/VVB HFM-478
From:	Alfred V. Del Grosso Ph.D. HFM-406 OVRR/DPQ/PQLS Nora M. Etz , HFM-406 OVRR/DPQ/PQLS
Through:	Rajesh Gupta, Ph.D. HFM-407 OVRR/DPQ/PQLS
Subject:	CSL Limited Influenza Virus Vaccine (Afluria TM) STN: 125254/0 Review of Chemical Analytical Procedures

Review Summary: We have reviewed the following analytical procedures and associated validation studies submitted in the CMC section of this application.

Analytical Procedures:
QA6657     Taurodeoxycholate by -----
QA5030     Thimerosal by --------------------
QA6211     Thimerosal by ------------------------------------
QA5930     pH
QA6699     ------------------------------------------------------------
QA5567     Protein by -----------------------

The following questions should be asked of the manufacturer and commitments should be made prior to licensure:

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